Tissue restraining devices and methods of use

ABSTRACT

Tissue restraining systems and devices as well as methods of using these devices are disclosed herein. According to aspects illustrated herein, there is provided a tissue restraining device that may include an annuloplasty member having one or more contact points along a portion of the annuloplasty member in a spaced relation to one another. The tissue restraining device may also include a second anchor for placement in a substantially opposing, spaced relation to the annuloplasty member. A restraining matrix may extend from the contact points of the annuloplasty member to the second anchor.

RELATED APPLICATIONS

This application is a divisional patent application of U.S. patentapplication Ser. No. 13/476,010, filed May 20, 2012, which is acontinuation in part of U.S. patent application Ser. No. 13/300,328,filed on Nov. 18, 2011, and which claims priority to and the benefit ofU.S. Provisional Application No. 61/414,990 filed Nov. 18, 2010, U.S.Provisional Application No. 61/444,554 filed Feb. 18, 2011, U.S.Provisional Application No. 61/487,914 filed May 19, 2011, and U.S.Provisional Application No. 61/487,906 filed May 19, 2011. All of theseapplications are incorporated herein by reference in their entiretiesfor the teachings therein.

BACKGROUND

Various disease processes can impair the proper functioning of one ormore of valves of human heart. These include degenerative processes(e.g., Barlow's Disease, fibroelastic deficiency), inflammatoryprocesses (e.g., Rheumatic Heart Disease) and infectious processes(e.g., endocarditis). In addition, damage to the ventricle from priorheart attacks (i.e., myocardial infarction secondary to coronary arterydisease) or other heart diseases (e.g., cardiomyopathy) can distort thevalve's geometry causing it to dysfunction.

The benefits of valve repair over replacement are well established inthe cardiac surgical literature in all types of valve dysfunction and innearly all disease states. Patients undergoing valve repair have beenshown to live longer, with better preservation of cardiac function. Thevast majority of patients with mitral or tricuspid regurgitation canhave their valves successfully repaired instead of replaced. Thelikelihood of a successful repair, however, is highly dependent on theskill, knowledge and experience of the individual surgeon. Although mostsurgeons are comfortable performing simple valve repairs (annuloplastymembers, limited leaflet resections, etc.), many rarely perform valverepairs and only a small minority of surgeons are comfortable at morecomplex valve repairs. Most surgeons have inadequate knowledge andtraining in these techniques and, even if they had the technicalability, they do not encounter enough patients to feel comfortable withcomplex cases. This variability in surgical skill is reflected in thewide range of valve repair rates among different centers. High-volume,experienced centers routinely report valve repair rates over 90% whilethe national average is only 20-30%.

Since they involve work inside the heart chambers, conventionalprocedures for replacing or repairing cardiac valves require the use ofthe heart-lung machine (cardiopulmonary bypass) and stopping the heartby clamping the ascending aorta and perfusing it with high-potassiumsolution (cardioplegic arrest). Although most patients tolerate limitedperiods of cardiopulmonary bypass and cardiac arrest well, thesemaneuvers are known to adversely affect all organ systems. The mostcommon complications of cardiopulmonary bypass and cardiac arrest arestroke, myocardial “stunning” or damage, respiratory failure, kidneyfailure, bleeding and generalized inflammation. If severe, thesecomplications can lead to permanent disability or death. The risk ofthese complications is directly related to the amount of time thepatient is on the heart-lung machine (“pump time”) and the amount oftime the heart is stopped (“crossclamp time”). Although the safe windowsfor pump time and cross clamp time depend on individual patientcharacteristics (age, cardiac reserve, comorbid conditions, etc.), pumptimes over 4 hours and clamp times over 3 hours can be concerning evenin young, relatively healthy patients. Complex valve repairs can pushthese time limits even in the most experienced hands. Even if he or sheis fairly well versed in the principles of mitral valve repair, a lessexperienced surgeon is often reluctant to spend 3 hours trying to repaira valve since, if the repair is unsuccessful, he or she will have tospend up to an additional hour replacing the valve. Thus, time is amajor factor in deterring surgeons from offering the benefits of valverepair over replacement to more patients. Devices and techniques whichsimplify and expedite valve repair would go a long way to eliminatingthis deterrent.

Within recent years, there has been a movement to perform many cardiacsurgical procedures “minimally invasively” using smaller incisions andinnovative cardiopulmonary bypass protocols. The purported benefits ofthese approaches include less pain, less trauma and more rapid recovery.However the use of these minimally invasive procedures has been limitedto a handful of surgeons at specialized centers. Even in their hands,the most complex valve repairs cannot be performed since dexterity islimited and the whole procedure moves more slowly. Devices andtechniques which simplify valve repair have the potential to greatlyincrease the use of minimally invasive techniques which wouldsignificantly benefit patients.

SUMMARY

Tissue restraining systems and devices as well as methods of using thesedevices are disclosed herein. According to aspects illustrated herein,there is provided a tissue restraining device that may include a firstanchor having one or more contact points along a portion of the firstanchor in a spaced relation to one another. The tissue restrainingdevice may also include a second anchor for placement in a substantiallyopposing relation to the first anchor. A restraining matrix may extendfrom the contact points of the first anchor to the second anchor.

According to aspects illustrated herein, there is also provided a methodfor treating a prolapsed mitral valve. The method may include a step ofembedding an anchor into a tissue in a left ventricle and deployinganother anchor in a left atrium. A restraining matrix may be extendedbetween the anchors such that the restraining matrix is draped over themitral valve. Next, the restraining matrix may be adjusted to correct aprolapsing segment of the mitral valve.

According to aspects illustrated herein, there is also provided a devicefor gaining access to a body organ that includes a first extensionmember and a second extension member in a substantially parallelrelation to one another and coupled an elongated body, each having atleast one inner lumen in communication with one or more inner lumens ofthe elongated member. The device may also include a deflection mechanismdisposed on one of the extension members and configured to deflect thesecond extension member relative to the first extension member uponactivation, such that the inner lumen of the second extension member isaligned with a body organ to which access is needed.

According to aspects illustrated herein, there is also provided a methodfor gaining access to the left atrium of a heart. The method may includea step of navigating a first extension member of an elongated deviceover a guidewire to position a distal tip of the first extension memberin proximity to a coronary sinus ostium. Next, a second extension memberof the elongated device may be deflected radially away form the firstextension member. In the next step, another guidewire may be advancedthrough the second extension member to penetrate across tissue into theleft atrium for subsequent delivery of an implant into the left atriumover the guidewire.

According to aspects illustrated herein, there is provided a tissuerestraining device that may include an annuloplasty member forattachment to a valve annulus. The tissue restraining device may alsoinclude an anchor for placement in a spaced relation to the annuloplastymember. A restraining matrix may extend from the annuloplasty member tothe anchor.

According to aspects illustrated herein, there is also provided a methodfor treating a prolapsed mitral valve. The method may include a step ofattaching an annuloplasty member substantially along the valve annulus.Next, an anchor is embedded into a tissue in a left ventricle anddeploying another anchor in a left atrium. A restraining matrix maysubesquently be extended between the annuloplasty member and the anchorsuch that the restraining matrix is draped over the mitral valve. Next,the restraining matrix may be adjusted to correct a prolapsing segmentof the mitral valve.

According to aspects illustrated herein, there is provided a kit forrestraining tissue comprising that may include a restraining matrixhaving a proximal end and a distal end, with an attachment memberdisposed at the proximal end of the restraining matrix and designed toattach to an annuloplasty ring. The kit may further include an anchorconfigured for attachment to the distal end of the restraining matrix.

BRIEF DESCRIPTION OF DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1A and FIG. 1B illustrate embodiments of a tissue restrainingdevice of the present disclosure.

FIG. 2 illustrates an embodiment of an anchor suitable for use in tissuerestraining devices of the present disclosure.

FIG. 3 illustrates an embodiment of an anchor suitable for use in tissuerestraining devices of the present disclosure.

FIG. 4 illustrates an embodiment of an anchor suitable for use in tissuerestraining devices of the present disclosure.

FIG. 5A and FIG. 5B illustrate an embodiment of an anchor suitable foruse in tissue restraining devices of the present disclosure.

FIG. 6A and FIG. 6B illustrate embodiments of an anchor suitable for usein tissue restraining devices of the present disclosure.

FIG. 7A and FIG. 7B illustrate embodiments of a restraining matrixsuitable for use in tissue restraining devices of the presentdisclosure.

FIG. 8 illustrates an embodiment of a tissue restraining device of thepresent disclosure.

FIG. 9 illustrates an embodiment of a tissue restraining device of thepresent disclosure.

FIG. 10A illustrates an embodiment of a tissue restraining device of thepresent disclosure loaded into a sheath of a delivery catheter fordelivery to implantation site.

FIGS. 10B-10D illustrate an embodiment delivery catheter for deliveringa tissue restraining device of the present disclosure to implantationsite.

FIGS. 11A-11L illustrate a method for mitral valve repair using a tissuerestraining device of the present disclosure.

FIGS. 12A-12F illustrate various suitable embodiments of deliverycatheters for delivering tissue restraining devices of the presentdisclosure.

FIG. 13A and FIG. 13B illustrate various embodiments of a tissuerestraining device of the present disclosure.

FIG. 14 illustrates an embodiment of a tissue restraining device of thepresent disclosure.

FIGS. 15A-15G illustrate a method for mitral valve repair using a tissuerestraining device of the present disclosure.

FIG. 16 illustrates an embodiment of a tissue restraining device of thepresent disclosure in a disassembled state.

FIGS. 17A-17C illustrate embodiments of a first anchor of the tissuerestraining device of the present disclosure.

FIG. 18A and FIG. 18B illustrate embodiments of a sheath of the tissuerestraining device of the present disclosure.

FIG. 19 illustrates an embodiment of a tissue restraining device of thepresent disclosure in an assembled state.

FIG. 20 illustrates an embodiment of a tissue restraining device of thepresent disclosure implanted adjacent to a mitral valve.

FIGS. 21A-21C illustrate another method for mitral valve repair using atissue restraining device of the present disclosure.

FIGS. 22A-22B is a schematic view of an embodiment of a system foraccessing a body organ of the present disclosure.

FIG. 23 is a schematic view of another embodiment of a system foraccessing a body organ of the present disclosure.

FIGS. 24A-24C illustrate various shapes of an embodiment of a deflectionmechanism of the present disclosure

FIGS. 25A-25B illustrate another embodiment of a deflection device ofthe present disclosure.

FIGS. 26A-26B illustrate yet another embodiment of a deflection deviceof the present disclosure.

FIG. 27A illustrates an embodiment of a system for accessing a bodyorgan of the present disclosure where a deflection mechanism isintegrated with a stopper.

FIG. 27B illustrates an embodiment of a system for accessing a bodyorgan of the present disclosure where a deflection mechanism is distinctfrom a stopper.

FIGS. 28A-28F show an embodiment method of using a system for accessinga body organ of the present disclosure.

FIGS. 29A-29N illustrate steps of an exemplary procedure to restrain anative mitral valve in vivo using a tissue restraining device of thepresent disclosure.

FIG. 30 and FIG. 31 illustrate an embodiment of a tissue restrainingdevice having an annuloplasty member.

FIG. 32 illustrates an embodiment of a tissue restraining device of thepresent disclosure.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

There is provided a tissue restraining device for minimally invasiverepair of a prolapsing tissue. Referring to FIG. 1, a tissue restrainingdevice 100 comprises a first anchor 112, a second anchor 114, and arestraining matrix 116 extending between the anchors 112, 114. Therestraining matrix 116, in one embodiment, may be formed by one or morerestraining cords 118. The restraining cords 118, in an embodiment mayeach be individually adjustable cord.

In an embodiment, as shown in FIG. 1A, the first anchor 112 may includeone or more inner lumens 122 a, 122 b extending through at least aportion of the first anchor 112. In an embodiment, the inner lumens 112a, 122 b may be sized to receive a guidewire therethrough. In anembodiment, inner lumens 122 a, 122 b can extend substantially for theentire length of the first anchor 112. In embodiments with multiplelumens, the lumens may be in adjacent relation to one another,concentric relation to one another, or a combination thereof. To theextent desired, the inner lumens 122 a, 122 b may be in communicationwith one another.

The first anchor 112 may further include one or more contact points 123positioned along at least a portion of the first anchor. The contactpoints 123 can be the points at which the restraining cords 118 contactthe first anchor 112. In an embodiment, a proximal end of eachrestraining cord 118 may be fixed to the first anchor 112 at contactpoints 123, such as by adhesive, weld or other similar attachments. Inan embodiment, as shown in FIG. 1B, the contact points 123 may be one ormore of openings 124 positioned along at least a portion of the firstanchor 112, such that the restraining cords 118 can be inserted into thefirst anchor 112 or can extend out from the first anchor, throughopenings 124. In an embodiment, the first anchor includes a plurality ofopenings 124. In an embodiment, the openings 124 may be spaced apart,evenly or unevenly, from one another and may be configured to accept oneor more individual cords of the plurality of restraining cords 118. Oneor both inner lumens 122 a, 122 b may be in communication with theplurality of openings 124, such that the restraining cords 118 can bepassed through the inner lumens 122 a, 122 b and out of the plurality ofopenings 124 to form the restraining matrix 116.

As is described in more detail below, the first anchor 112 may be of anyshape, but such factors as, for example, the desired shape of therestraining matrix 116 and the shape or location of a tissue to berestrained may play a role when shaping the first anchor 112. In anembodiment, the first anchor 112 may be provided with a shape thatapproximates the shape of tissue or structure to which the first anchor112 is to be attached. In this manner, when the first anchor 112 isdeployed, the first anchor 112 does not act to substantially alter thenatural shape of the tissue or structure to which the first anchor 112is attached. By way of a non-limiting example, the first anchor 112 fora tissue restraining device of the present disclosure to be used forrestraining a prolapsed mitral valve, which is generally circular, mayhave a generally elongated shape with inwardly curved ends.

In an embodiment, the first anchor 112 may be designed for securedplacement at or near a tissue to be restrained. The first anchor 112 maybe permitted to secure to tissue based on (a) its construction, such as,for example, if the first anchor includes design elements configured togrip a tissue therebetween; (b) its shape, such as, for example, if thefirst anchor is shaped to enclose a tissue or penetrate a tissue, (c)its secondary design elements, such as, for example, by using anchoringpins or stents, or (d) a combination thereof.

FIG. 2 illustrates a non-limiting embodiment of the first anchor 112, inwhich the first anchor 112 includes a first arm 202, which has a firstend 202 a and a second end 202 b, and a second arm 204, which has afirst end 204 a and a second end 204 b. As will be described in detailbelow, the arms 202, 204 may be connected in such a manner so as tocooperate with one another to facilitate pinching a structure, such as atissue, between the arms. In an embodiment, the first arm 202 may beplaced into a coronary sinus and the second arm 204 may be placed in theleft atrium, and the arms 202, 204 may be biased toward one another topinch the common wall between the coronary sinus and the left atrium,thus securing the tissue restraining device in place in proximity to amitral valve. In an embodiment, the second end 202 b of the first arm202 may be connected to the first end 204 a of the second arm 204,forming an apex 206. It should be noted, however, that the first arm 202may be connected to the second arm 204 anywhere along the length of thesecond arm 204, and vice versa. For example, in an embodiment shown inFIG. 3, the first anchor 112 includes a first arm 202 connected to asecond arm 204 in the middle section of the second arm 204. The arms202, 204 may be of similar length or different lengths. In anembodiment, the second arm 204 is longer than the first arm 202.

The first arm 202, as shown in FIG. 2, may include one or more innerlumens 210 extending through at least a portion of the first arm 202.The second arm 204 may also include one or more inner lumens 212extending through at least a portion of the second arm 204. Inembodiments with multiple lumens in each arm, the lumens in each armwhile may be adjacent to one another, concentric in relation to oneanother, or a combination thereof. In an embodiment, each arm mayinclude two lumens, each being adjacent to the another. In addition, thesecond arm 204 may include a plurality of openings 124 positioned alonga side of the second arm 204 in spaced relation to one another, being incommunication with the one or more inner lumens 210, 212.

FIG. 4 illustrates another non-limiting embodiment of the first anchor112. The first anchor 112, as shown, includes a first arm 202, having afirst end 202 a and a second end 202 b, and a second arm 204, having afirst end 204 a and a second end 204 b. The arms 202, 204 may beconnected through an end cup 410, which can act to bias the arms 202,204 toward one another. In an embodiment, the hub 410 may include anumber of channels 410 a, 410 b, 410 c. These channels 410 a, 410 b, 410c may be in communication with the inner lumens of the first arm 202 andthe second arm 204 so as to allow a guidewire or the restraining cords118 to pass through the hub into the first arm 202 or the second arm204. In an embodiment, the second arm 204 can comprise multiple sub-arms406 and 408, with each of the sub-arms 406, 408 having one or more innerlumens. It will of course be understood that various other embodimentsin terms of the number of sub-arms, and whether the second arm 204, thefirst arm 202, or both can include multiple sub-arms are possible.

In an embodiment, the first arm 202 and the second arm 204 may be biasedtoward one another in order to facilitate a secured placement of thefirst anchor to a tissue to be restrained or in proximity to suchtissue. This can be achieved in a variety of ways. In an embodimentshown in FIG. 2, the apex 206 may be shaped in such a way as to bias thearms 202 and 204 toward one another. In another embodiment shown in FIG.3, the first arm 202 may be connected to the second arm 204 by a hinge306, which can force the arms toward one another. In yet anotherembodiment shown in FIG. 4, the second end 202 b of the first arm 202and the first end 204 a of the second arm 204 may be inserted into theend cup 401, which can act to bias the arms 202, 204 toward one another.FIGS. 5A-5B demonstrate yet another embodiment, in which the firstanchor 112 comprises a first arm 202 and a second arm 204, wherein ashape-memory wire 506 may extend along the arms 202, 204 to bias thearms 202, 204 toward one another when the first anchor 112 is deployed.Of course, a combination of the foregoing methods or any other method,in addition to or instead of the foregoing methods, may be employed tobias the arms toward one another and still remain within the spirit andscope of the present invention.

In an embodiment, the first anchor 112 may be made of any medical grade,biocompatible material. Depending on whether a tissue to be restrainedby the instant device requires a permanent or only a temporary support,the first anchor may be made of a bioresorbable or non-bioresorbablematerial. Suitable non-bioresorbable materials include, but are notlimited to, metals such as titanium, nickel-titanium alloy, andstainless steel, and plastics, such as polyethylene, polypropylene, andpolyurethane, among many others. Suitable bioresorbable materialsinclude, but are not limited to, polyglycolic acid, polylactic acid, andpolydioxanone, among many others.

To facilitate the deployment of the first anchor 112, in someembodiments one or both arms 202, 204 of the first anchor 112 maycomprise a shape memory material, such as nickel-titanium alloy ornitinol, copper-zinc-aluminum alloy, copper-aluminum-nickel alloy,iron-manganese-silicon alloy, iron-nickel-aluminum alloy, gold-cadmiumalloy, or combinations thereof. In an embodiment, the first anchor 112may be made of a soft, multi-lumen plastic tubing having a nitinol wiredisposed in one of its inner lumens, as shown in FIGS. 5A-5B.Alternatively or additionally, the first anchor 112 may be made of ashape memory tubing.

In an embodiment, as shown in FIG. 30, the first anchor 112 may be anannuloplasty member 3000 that may be implanted into a defective valve3005 substantially along a portion of a valve annulus 3007. In anembodiment, the annuloplasty member 3000 may be conformable to themovement of the surface of the valve annulus. The annuloplasty member3000 may include an inner core made of metal, such as stainless steel ortitanium, or of a flexible material, such as silicone rubber or Dacroncordage, covered with a biocompatible fabric or cloth. The annuloplastymember 3000 of the present disclosure may be rigid, semi-rigid orflexible, and may form a complete continuous ring, a split ring or apartial ring or band. Further, the annuloplasty member 3000 may beprovided in one of several shapes, including, but not limited to,circular, D- or “kidney” shaped, C-shaped, irregular shapes or othershapes suitable for implantation into a heart valve. In an embodiment,the annuloplasty member 3000 may be specifically designed for the mitralor tricuspid valve repair. In an embodiment, the annuloplasty member3000 of the present disclosure is a one-piece ring or band.Alternatively, the annuloplasty member 3000 of the present disclosure isformed with two or more interconnected pieces.

The annuloplasty member 3000 may be attached to tissue in proximity tothe valve annulus 3007 by a variety of conventional techniques. Forexample, the annuloplasty member 3000 may implanted into the defectivevalve by means of a plurality of interrupted mattress sutures which maybe sewn through the annuloplasty member 3000 and into the valve annulus3007. Other suitable for attaching the annuloplasty member 3000 into thevalve include, but are not limited to, a continuous running suture,interrupted simple (non-mattress) sutures, specialized clips or staples,or other means known and used in the art. In the embodiments where theannuloplasty member 3000 includes an outer layer of fabric or cloth,sutures, clips or staples can the annuloplasty member 3000 may besutured or stapled to the valve 3005 through the fabric or cloth, butcan of course also be sutured through both the inner core in addition tothe fabric or cloth.

As shown in FIG. 30, the annuloplasty member 3000 may include ananterior section 3002 and a posterior section 3004. When theannuloplasty member 3000 is implanted into the valve 3005 the anteriorsection 3002 may be attached to the anterior portion of the valveannulus 3007. The posterior section 3004 of the annuloplasty member 3000may be attached to the posterior portion of the valve annulus 3007. Inan embodiment, the annuloplasty member 3000 may include commissuralmarks as guides to identify the approximate location of the valvecommissures and separate the annuloplasty member into the anteriorsection 3002 and posterior section 3004 to assist in orienting theannuloplasty member 3000 for implantation into the valve 3005.

Depending on whether the tissue restraining device 100 is used to repaira prolapse in the posterior leaflet, anterior leaflet, or both, therestraining matrix 116 can be attached to the posterior section 3004,anterior section 3002, or a restraining matrix can be attached to boththe posterior section 3004 and the anterior section 3002. By way ofnon-limiting example, FIGS. 30 and 31 illustrate the restraining matrix116 attached to the posterior section 3004 and this embodiment isdescribed below, however, the restraining matrix 116 can be attached tothe anterior section 3002 in a similar manner. As shown in FIGS. 30 and31, the restraining matrix 116 may, in an embodiment, be attached to theposterior section 3004 of the annuloplasty member 3000. In this manner,when the annuloplasty member 3000 is implanted, the restraining matrix116 may be passed into the left ventricle to drape over the posteriorleaflet 3006 of the valve 3005 to restrain the posterior leaflet 3006.The matrix 116, in an embodiment, may be formed from a plurality ofrestraining cords 118 that extend from a plurality of contact pointsdisposed along the posterior section 3004 of the annuloplasty member3000. In an embodiment, the plurality of restraining cords 118 can passthrough an interior lumen within the annuloplasty member 3000 and exitthe annuloplasty member 3000 through a plurality of spaced apartopenings disposed along the posterior section 3004. In an embodiment,the restraining matrix 116 is permanently attached to the annuloplastymember. In an alternative embodiment, the restraining matrix 116 may beremovably attached to the annuloplasty member 3000. To that end, in anembodiment, the end of the restraining matrix to be attached to theannuloplasty member 3000, or another type of the first anchor 112, maybe equipped with an attachment member that can removably attach therestraining matrix 116 to the annuloplasty member. In an embodiment, theattachment member may be an open tube configured to snap onto theannuloplasty member 3000. In an embodiment, the attachment member mayinclude a plurality of hooks configured for insertion into the annularmember 3000 to attach the restraining matrix to the annular member. Inyet another embodiment, the restraining matrix 116 may be attached tothe annuloplasty member 3000 by tying proximal ends of the restrainingcords to the annuloplasty member 3000. Of course it will be understoodthat in some embodiments the attachment member may be configured topermanently attach the restraining matrix to the annuloplasty member3000 or another type of the first anchor 112.

Similar to the first anchor 112, the second anchor 114 facilitatessecure placement of the instant device in proximity to a tissue to berestrained. The second anchor 114 can also be made of any medical grade,biocompatible material as described in connection with the first anchor.The second anchor 114 may be made of the same or different material asthe first anchor 112. As is described in more detail below, the secondanchor 114 may be of any shape, but such factors as, for example, thedesired shape of the restraining system and the shape or location of atissue to be restrained may play a role when selecting a shape for thesecond anchor 114.

By way of a non-limiting example, FIG. 6A illustrates an embodiment of asecond anchor 114 suitable for use in a tissue restraining device of thepresent disclosure. The second anchor 114 comprises an anchoring member602 and a locking member 604, one or both of which may be configured toaccept a plurality of restraining cords 606 therethrough. Alternativelyor additionally, a similar locking mechanism can be disposed on thefirst anchor 112 for locking proximal ends of individual restrainingcords 118. Referring to FIG. 6B, in another embodiment, the secondanchor 114 may be a helical coil with a sharpened distal tip, such thatthe second anchor 114 can be embedded into tissue by rotation. Otherembodiments of the second anchor are also possible as long as the secondanchor 114 can be securely implanted into tissue of the left ventricleand can provide sufficient support to the restraining matrix.

Referring back to FIG. 1A and FIG. 1B, the restraining matrix 116 mayextend between the first anchor 112 and the second anchor 114. Thematrix 116, in an embodiment, may be formed from a plurality ofrestraining cords 118 that extend from the plurality of contact points123 of the first anchor 112 to the second anchor 114. In an anotherembodiment, the plurality of restraining cords 118 can be disposedwithin the first anchor 112 and exit the first anchor 112 through theplurality of openings 124. For example, the plurality of restrainingcords 118 can be directed to pass through one or more inner lumens 122a, 122 b and exit the first anchor 112 through the plurality of openings124. In an embodiment, each of the plurality of openings 124 may acceptone individual cord of the plurality of restraining cords 118. Inanother embodiment, each of the plurality of openings 124 may acceptmultiple individual cords of the plurality of restraining cords 118.

The individual restraining cords of the plurality of restraining cords118 can extend for a distance until they can be attached, individuallyor as a bundle, to the second anchor 114. The number of individualcords, the size of the cords, and the distance between the cords mayvary depending on particular characteristics of a tissue to berestrained and the application being implemented. In general, while therestraining matrix 116 needs to provide sufficient support to a tissueto be restrained, it may be desirable to minimize the surface area ofthe restraining matrix to decrease the amount of prosthetic material inthe device and, which may improve the safety and cost effectiveness ofthe device. To that end, the individual cords, in embodiment, may bemade from either monofilament or multifilament material.

In an embodiment, the restraining matrix 116 can be adjustable byadjusting the restraining cords 118 to provide a desired support to theprolapsing tissue. In an embodiment, individual cords 118 can beadjusted independently of one another. In an embodiment, the individualcords may be adjusted either proximally of the first anchor 112, i.e.before entering the first anchor, or distally of the second anchor 114,i.e. after exiting the second anchor, or both. To that end, in anembodiment, a locking member 604 may be disposed either adjacent to thefirst anchor, the second anchor, as described above, or both. To adjustthe cords in such embodiments, the locking member may be deactivated,each individual cord 118 may be tightened or loosened as desired, and,when the desired restraining matrix support is achieved, the lockingmember may be activated to maintain the individual cords 118 inposition. It will be understood that the restraining cords 118 may befixated or maintained using any other device instead of or in additionto a locking member. In addition, it should be mentioned that thelocking member may be any locking member known in the art.

In an embodiment, the individual cords 118 may be made of any suitablebiocompatible material. Depending on whether a tissue to be restrainedby the instant device requires a permanent or only a temporary support,the cord may be made of a bioresorbable or non-bioresorbable material.Suitable non-bioresorbable materials include, but are not limited to,polytetrafluoroethylene (PTFE), nylon, and polypropylene, among manyothers. Suitable bioresorbable materials include, but are not limited topolyglycolic acid, polylactic acid, and polydioxanone, among manyothers.

In reference to FIGS. 7A and 7B, in an embodiment, in addition to aplurality of restraining cords 118 extending substantiallylongitudinally between the anchors 112, 114, the restraining matrix 116may also include cross-restraint members 710, which extend transverselybetween individual cords of the plurality of restraining cords 118. Inan embodiment, the cross-restraint members 710 may run parallel to oneanother, as shown in FIG. 7A. In an embodiment, the cross-restraintmembers 710 may criss-cross one another, as shown in FIG. 7B. In anembodiment, some cross-restraint members may run parallel to oneanother, while others criss-cross other cross-restraint members.

The restraining matrix 116 in embodiment can have any geometric shape orpattern. In general, the shape or pattern of the matrix may depend onthe shape of a tissue to be restrained. In an embodiment, the shape ofthe restraining matrix may be selected so the restraining matrixprovides sufficient support to a prolapsing region to be restrained. Theshape or pattern of the matrix may at least in part be dictated by theshapes of the first anchor and/or the second anchor. In an embodiment,the design of the first anchor, the second anchor, or both may beselected in such a manner as to ensure that the restraining systemextends over the entire prolapsing region to be restrained.

By way of a non-limiting example, FIG. 8. illustrates a tissuerestraining device 800 suitable for restraining a prolapse in a heartvalve having a generally circular shape. The tissue restraining device800 includes a first anchor 812, a second anchor 814, and a restrainingmatrix 816. The first anchor 812 may have a generally elongated shapewith inwardly curved ends and the second anchor 814 may have an apicalend at which the individual cords may be collected together, thusforming a substantially triangular restraining matrix. In general, thefirst anchor 812, the second anchor 814, and the restraining matrix 816may have features described above in relation to various embodiments ofthe first anchor 112, second anchor 114 and restraining matrix 116. Inthe particular embodiment shown in FIG. 8, the first anchor 812comprises a first arm 802 and a second arm 804, however, the firstanchor 812 may only include a single arm or more than two arms.Moreover, although not shown in FIG. 8, each arm may comprises multiplesub-arms as described above and may have different shapes. In anembodiment, the first arm 802 and the second arm 804 may each have oneor more inner lumens through which a guidewire, restraining cords orboth can be passed.

To form the restraining matrix 816, a plurality of restraining cords 818can extend between the first anchor 812 and the second anchor 814. In anembodiment, the restraining cords 818 can connect to the first anchor812 at the plurality of contact points, as described above. In anembodiment, the plurality of restraining cords 818 can be directedthrough a one or more lumens (not shown) of the first arm 802, throughone or more inner lumens of the second arm 804 and out of the second arm804 through the plurality of openings 824. In an embodiment, the one ormore inner lumens of the first arm 802 and the one or more inner lumensof the second arm 804 may be in communication with one another, that is,the plurality of restraining cords can pass from one arm to the otherarm without exiting the device 800. In an embodiment, the inner lumensof the first arm 802 the inner lumens of the second arm 804 may not bein communication with one another, and thus, an exit or openings may beprovided at or near the second end 802 b of the first arm 802 and at ornear the first end 804 b of the second arm 804, respectively to permitpassing of the cords 818 from one arm to the other. Of course, one ormore exit openings may still be provided even when the inner lumens ofthe entrance and exit arms are in direct communication with one another.

The plurality of restraining cords 818 may be separated inside the oneor more inner lumens of the second arm 804 to exit the second arm 804through the plurality of openings 824. The individual cords of theplurality of restraining cords 818 may extend for a distance forming therestraining matrix 816 until they can be collected into a bundle 827before passing through the second anchor 814. The number of individualcords forming the matrix and the distance between individual cords mayvary as long as the matrix provides adequate support to a mitral valvein need of repair. By way of a non-limiting example, the standardteaching in mitral valve repair is that the free margin of a leafletmust be supported by a good quality cord (i.e., one that is notelongated or too thin) at least every 5-7 millimeters along the leaflet.Using this guideline, the individual cords may be preferably spaced at asimilar interval or slightly wider. In an embodiment, the individualcords may be evenly spaced. In an embodiment, the individual cords maybe spaced unevenly or may have varying thickness to accommodate varyingprolapsing forces.

By way of a non-limiting example, FIG. 9. illustrates a tissuerestraining device 900 suitable for restraining a prolapsed tissuehaving a generally elongated shape. The tissue restraining device 900includes a first anchor 912, a second anchor 914, and a restrainingmatrix 916. The first anchor 912, the second anchor 914, and therestraining matrix 916 may have features described above in relation tovarious embodiments of the first anchor 112, second anchor 114 andrestraining matrix 116. As shown in FIG. 9, both the first anchor 912and the second anchor 914 may have a generally elongated shape, thusforming a substantially rectangular restraining matrix. It will beunderstood that by the shape of the restraining matrix can be customizedto fit a particular application by changing the size and shape of thefirst anchor, the second anchor or both.

FIG. 30, FIG. 31 and FIG. 32 demonstrate another embodiment of arestraining matrix 116 having a substantially triangular shape. In anembodiment, the individual restraining cords 118 may come together at anapex 3011 of the restraining matrix 116 and a strand 3013 may extenddistally from the apex 3011 toward the second anchor 114. In such anembodiment, the tension of the restraining matrix 116 may be adjusted bypulling on the strand 3013. In an embodiment, the individual restrainingcords 118 may be adjustable at or proximally of the first annuloplastymember 3000. In an embodiment, the individual restraining cords 118 maybe fixed to the annuloplasty member, such that the tension of therestraining matrix 116 as a single unit may be adjusted by pulling onthe strand 3013. It should of course be understood that although therestraining matrix 116 is illustrated having individual cords 118 joinedat the apex 3011, any other designs may be possible, so long as a theindividual cords can be connected for ease of handling during operation.

In an embodiment, the second anchor 114 may be provided with a loop 3012to allow the strand 3013 to be passed through the loop before the strand3013 may return to the first anchor 112. In an embodiment, the strand3013 may be passed between the leaflets of the valve 3005 and may bejoined to the annuloplasty member 3000. The strand 3013 may be joined tothe annuloplasty member 3000 anywhere along the posterior section 3004,including, but not limited to, either end of the posterior section 3004near a commisure or in the middle of the posterior section 3004. In anembodiment, the strand 3013 may be passed through the annuloplastymember 3000. In such an embodiment, the tension of the restrainingmatrix 116 may be adjusted by pulling on the strand 3013. In anembodiment, another strand 3015 may be fixedly disposed on theannuloplasty member 3000 so that the strands 3013, 3015 can be joined tomaintain a desired tension in the restraining matrix 116, as shown inFIG. 31. Additionally or alternatively, in embodiments where theindividual restraining cords 118 are adjustable at the first anchor 112,the strand 3013 can be joined to the proximal ends of one or morerestraining cords 118. The strands and/or cords can be joined togetherwith a knot or by another conventional techniques, such as gluing,welding, melting, or similar. It will of course be understood that othermeans for tightening the restraining matrix 116 besides with the strand3013 may be provided. Similarly, other designs that can allow attachmentof the strand 3013 or apex 3011 to the second anchor 112 are alsocontemplated. By way of a non-limiting example, the restraining matrix116 may be provided with a chain of loops extending from the apex 3011and the second anchor 114 may be provided with a hook, such that thechain of loop can be pulled toward the second anchor 114 to tighten therestraining matrix 116 and a loop of the chain of loops may be hookedinto the second anchor 114 to maintain tautness of the restrainingmatrix 116. In an embodiment, distal ends of the restraining cords maybe passed through the loop of the second anchor 114, instead of a singlestrand, as described above. In an embodiment, the distal ends of therestraining cords 118 may be fixed at the second anchor, such that therestraining matrix 116 may be performed by adjusting the restrainingcords 118 at or proximally of the first anchor. Finally, it should beunderstood that although this embodiment of the restraining matrix 116is described in connection with the device 100 having the annuloplastymember 3000, this embodiment of the restraining matrix 116 another typeof the first anchor 112, such as for example, a hairpin-shaped firstanchor 112, as shown in FIG. 32.

In operation, as mentioned above, tissue restraining devices of thepresent disclosure may be suitable for restraining various tissues. Inreference to FIG. 10A, a suitable embodiment of a tissue restrainingdevice 100 of the present disclosure may be loaded into a sheath 1002 ofa delivery catheter for delivery through a guide catheter 1004 to atissue to be restrained. As shown in FIG. 10A, in an embodiment, theentire tissue restraining device 100, including the first anchor 112,the second anchor 114, and the restraining matrix 116, can be loadedinto the sheath 1002. However, to the extent desired, only a portion ofthe tissue restraining device 100 may be loaded into the sheath 1002.When one or both of the anchors of the device 100 are secured in theproximity of a tissue to be restrained, the sheath 1002 can be retractedto deploy the device 100. The restraining matrix 116 of the device 100can be positioned to drape over a tissue in need of support. In anembodiment where the restraining cords forming the matrix areindividually adjustable, the restraining cords 118 of the device 100 maybe adjusted until all prolapsing segments of the tissue in need ofsupport are corrected. Once the individual cords 118 have been adjusted,the individual cords 118 can be locked in position.

FIG. 10B demonstrates an embodiment delivery catheter 1050. In anembodiment, the delivery catheter 1050 may include an outer sheath 1052,which forms a proximal portion 1051 of the delivery catheter 1050. Thedelivery catheter 1050 may also include an inner sheath 1002, whichextends out of the outer sheath 1052 to form a distal portion 1053 ofthe delivery catheter 1050. The inner sheath 1002 may be slidablydisposed within the outer sheath 1052. The inner sheath 1002 may bedesigned to house a device to be delivered with the delivery catheter1050.

Referring to FIG. 10D, in an embodiment, the guide catheter 1050 mayinclude multiple inner lumens. In an embodiment, one or more guidewirescan be passed through the inner lumens of the delivery catheter 1050.Further, a number of tools for controlling the inner sheath 1002 and thedevice housed in the inner sheath 1002 can be passed though the innerlumens of the delivery catheter 1050. In an embodiment, the deliverycatheter 1050 is provided with an inner sheath tether 1055 for slidingthe inner sheath 1002 in relation to the outer sheath 1052.

By way of a non-limiting example, the delivery catheter 1050 may be usedto deliver the tissue restraining device 100 of the present disclosure.The tissue restraining device 100 may be loaded into the inner sheath1002 for delivery to the site of interest. Referring to FIG. 10C, theinner sheath 1002 may include a wider base region 1061 in which thefirst anchor 112 can be housed and an elongated distal region 1063 whichcan house the second anchor 114. In an embodiment, the inner sheath 1002may be split, as shown in FIG. 10C, to facilitate the delivery of anembodiment of the first anchor 112 with two arms 202, 204.

Referring again to FIG. 10D, in an embodiment, to control the tissuerestraining device 100, the delivery catheter 1050 can be provided witha first anchor pushrod 1057 for advancing the first anchor 112 out ofthe inner sheath 1002, a second anchor pushrod 1058 for advancing thesecond anchor 114 from the inner sheath 1002, an restraining matrixtether 1059 for adjusting the restraining matrix 116, and combinationsthereof. It should be noted that in an embodiment some of the controltools 1057, 1058 and 1059 may be adapted to serve multiple functions.

In an embodiment, tissue restraining devices of the present disclosuremay be employed to restrict a mitral heart valve 1100, as shown in FIGS.11A-11K. A guide wire 1102 may be advanced into coronary sinus (CS) vein1104 to a target entry point 1106 into the left atrium. A guide catheter1108 may be advanced over the guide wire 1102 and positioned with itstip aiming at the target entry point. Suitable embodiments of guidecatheters include, but are not limited to, embodiments presented inFIGS. 12A-12F. FIGS. 12A-12B illustrates a delivery catheter with aright angle distal tip 1210. FIGS. 12C-12D illustrate an embodiment of adelivery catheter with right angle distal tip 1225 and a centeringballoon 1220. FIG. 12E-12F illustrate an embodiment of a deliverycatheter with lasso distal tip 1230. Next, access may be gained to theleft atrium 1110 from CS, and the guide wire 1102 and then the guidecatheter 1108 may be advanced into the left ventricle 1110. Anembodiment of a restraining device 100 of the present disclosure, suchas, by way of a non-limiting example, the device 800 presented in FIG.8, may be advanced inside a sheath, as discussed above, through theguide catheter 1108 into the deployment position. The second anchor 114of the device 100 may be removed from the guide catheter 1108 and may beanchored in the left ventricle 1110. The guide catheter 1108 may then beremoved and the sheath may be retracted to deploy the restraining device100.

In embodiments where the first anchor 112 includes a first arm 202 and asecond arm 204, such as for example shown in FIG. 2, 3, or 4, the tissuerestraining device 100 may be deployed with its first arm in CS and itssecond arm 204 in the left atrium. The arms cooperate together to pinchthe common wall between the CS and left atrium, thus securing the firstanchor 112 of the tissue restraining device 100 in place adjacent to themitral valve. Additionally or alternatively, to further secure thedeployed device 100 in place, anchoring pins 1304 or an anchoring stent1306 may be employed, as shown in FIGS. 13A and 13B. In yet anotherembodiment, as shown in FIG. 14, the second arm 204 of the first anchor112 may traverse a valve 1406 and extend up the side of the valve. Thesecond arm 204 may include a member 1408, which can be designed to comeinto contact with the valve to, among other things, prevent, or at leastminimize, sideway motion of the first anchor.

The restraining matrix 116 may be positioned to drape over the posteriorleaflet of the mitral valve and may be adjusted until all prolapsingsegments are corrected. Once the restraining matrix 116 has beenadjusted, they can be fixated in position and, optionally, trimmed toremove extra material. For example, in an embodiment, the second anchormay be as shown in FIG. 6. In such embodiment, the individual cords maybe bundled together before being pulled through the lumen in the secondanchor using a suture snare. The individual cords 118 may besufficiently long to ensure that the ends of the cords pass through thesecond anchor and remain outside the second anchor. Individual cords maybe tightened or loosened by pulling on individual cords. When thedesired support is achieved, the locking member may be activated topermanently secure the individual cords in position.

FIG. 11K illustrates an embodiment of the restraining device 100 in thedeployed position. The device 100 includes the first anchor 112,comprising a first arm 202 deployed in CS and a second arm 204 deployedin the left atrium, a second anchor 114 secured inside the leftventricular, and restraining matrix 116 extending between the firstanchor 112 and the second anchor 114 over the posterior leaflet of themitral valve 1100. The retraining matrix 116 is formed by a plurality ofrestraining cords 118. In an embodiment, the restraining cords 118 canbe adjustable to ensure that the restraining matrix provides adequatesupport to one or more prolapsing regions of the mitral valve 1100. In afurther embodiment, the restraining cords 118 are individuallyadjustable.

Another embodiment of a method for restraining a prolapsing mitral valveusing a tissue restraining device 100 of the present disclosure is shownin FIGS. 15A-15G. A guide wire 1509 may be advanced into coronary sinus(CS) to a point in proximity of the mitral valve 1501. Another guidewire1507 may be advanced near the ostium of the coronary sinus, into theleft atrium through the atrial septum and on to the left ventricle. Forclarity, the guidewire 1507 can be referred herein as a transeptalguidewire 1507 and the guidewire 1509 can be referred to herein as a CSguidewire 1509. The second anchor 114 can then be advanced over thetranseptal guidewire 1507 into the left ventricle 1503 and embedded intothe left ventricle apex 1505. In an embodiment, the first anchor 112 maybe advanced over both the transeptal guidewire 1507 and the CS guidewire1509, where the transeptal guidewire may be inserted into the second arm204 of the first anchor and the CS guidewire may be inserted into thefirst arm 202 of the first anchor 112. In this manner, once the firstanchor 112 is fully deployed, the first arm 202 is located in thecoronary sinus, while the second arm is located in the left atrium 1513.Because the first arm 202 and the second arm 204 are biased toward oneanother, the first arm 202 and the second arm 204 may pinch the commonwall 1510 between the coronary sinus and the left atrium to securelyattach the first anchor 112 in proximity of mitral valve 1501. In anembodiment, the point of connection of the arms 202, 204, such as, forexample, the apex 206 or the hub 410, may be wedged at the coronarysinus ostium. Deployment of the first and second anchor in this mannercauses the restraining matrix 116 to drape over the posterior leaflet ofthe mitral valve 1501. The restraining matrix 116 may be adjusted toensure that the restraining matrix provides a desired support toprolapsing regions of the mitral valve 1501. Subsequently, therestraining cords 118 can be fixated and cut.

By way of non-limiting example, a delivery catheter 1050 may be used todeploy the restraining device 100 as shown in FIGS. 15A-15G. To thatend, the delivery catheter 1050 may be advanced over the transeptalguidewire 1507 and the CS guidewire 1509 such that the distal region1063 of the inner sheath 1002 is advanced into the left ventricle. Atthis point, the inner sheath 1002 may be retracted using the sheathtether and the second anchor 114 may be advanced with the second anchorpushrod 1058 until the second anchor 114 is embedded into the tissue ofthe left ventricle, for example, the left ventricle apex. Next, theinner sheath 1002 may be further withdrawn to initiate the deployment ofthe first anchor 112. The first anchor 112 may be advanced using thefirst anchor pushrod 1057 until the first anchor is fully deployed fromthe delivery catheter 1050. Once the first anchor 112 is in a desiredposition, the restraining matrix 116 may be adjusted using therestraining matrix tether 1059 until restraining matrix 116 provides adesired support to prolapsing regions of the mitral valve 1501. When therestraining matrix 116 has been adjusted, the restraining matrix tether1059 can be cut and fixated. Lastly, the delivery catheter 1050 and theguidewires 1507, 1509 can be withdrawn.

FIG. 30 and FIG. 31 illustrate a non-limiting example of a method forrestraining a prolapsing mitral valve with a tissue restraining device100 having an annuloplasty member 3000 as the first anchor 112. In anembodiment, the tissue restraining device 100 may be delivered via anopen heart approach through an incision in the patient's chest. Suitableapproaches for implantation of the tissue restraining device 100 of thepresent disclosure include, but are not limited to, a full mediansternotomy, or less invasive partial sternotomy and a right (or lessfrequently left) full, partial or “mini” thoracotomy. It should ofcourse be understood that more or less invasive approaches can also beused. After the patient is connected to a heart-lung machine,cardiopulmonary bypass is initiated and, if desired, the heart isarrested, the mitral valve is exposed through an incision through theleft atrium or using a transeptal approach following an incision in theright atrium.

Once good exposure of the mitral valve 3005 has been achieved, theannuloplasty member 3000 maybe implanted along the valve annulus 3007 byany implantation technique currently utilized for annuloplasty memberimplantation, including, but not limited to, interrupted mattresssutures, a continuous running suture, interrupted simple (non-mattress)sutures, specialized clips or staples. Next, the second anchor 112 maybe passed through the valve into the left ventricle and attached to theapex using an appropriate instrument. In an embodiment where the distalend of the restraining matrix 116 is connected to the second anchorprior to implantation of the second anchor 114, this pulls therestraining matrix 116 into the left ventricle 3021 extending therestraining matrix 116 over the posterior leaflet of the mitral valve.The tension of the restraining matrix 116 may then be adjusted toprovide a desired support to the prolapsing segments and fixed in placeto maintain that tension. The valve 3005 can then be tested usingconventional techniques such as pressurizing the left ventricle 3021with saline and assessing for residual leakage and prolapse. Once theappropriate tension in the restraining matrix 116 has been achieved, therestraining matrix may be locked in place using one of the techniquesdescribed above. The procedure can then be completed according toconventional techniques.

In an embodiment, the tension of the restraining matrix 116 may beadjusted after the atrial incisions are closed, the heart is restratedand the patient has been weaned off the heart lung machine. Therestraining matrix 116 may be left loose. The atrial incision may beclosed with a running suture, while allowing the restraining matrix tobe tensioned from outside the heart, such as, by extending the proximalends of the restraining cords 118 or the strand 3013 and/3015 beyond theatrial incision. The atrial suture may then be tightened so it does notleak but not permanently tied. The heart may then be restarted and thepatient weaned off the heart lung machine Once the heart is beating onit own, the tension of the restraining matrix 116 may be preciselyadjusted with guidance by transesophageal echocardiogram or anothermedical imaging techniques until all excess leaflet motion is eliminatedor reduced, a good surface coaptation between the valve leaflets isestablished, the mitral regurgitation is corrected or combinationthereof. As described above, testing of the valve repair is typicallyperformed prior to closing atriotomy incisions by injecting saline intothe left ventricle until sufficient pressure develops to close the valveleaflets and assessing the coaptation of the leaflets and for anyresidual regurgitation. Although useful, this technique is limited bythe fact that the heart is flaccid and so the anatomy and physiology ofthe valve leaflet motion is not physiologic. Instead, the tissuerestraining device 100 allows adjustment of the leaflets to be performedunder actual physiologic conditions, i.e. with the heart beating on itsown, rather than under static conditions, which may result in a moreaccurate adjustment and improved outcome of the procedure. Inparticular, systolic anterior motion (SAM) may occur as a complicationof repair of a prolapsing mitral valve, possibly due to differentanatomic factors. The present technique allows the surgeon to watch howthe leaflets of the mitral valve coaptat under actual physiologicconditions before adjusting the tension in the restraining matrix toachieve the right level of coaptation between the leaflets of the mitralvalve, thus reducing postoperative risk of SAM. Once a satisfactoryrepair has been achieved, the restraining matrix 116 may be fixed tomaintain the desired tension, such as by pulling on the restrainingmembers 118 or strand 3013 extending beyond the suture line. In anembodiment, the restraining matrix 116 may be tightened by instrumentspassed through the united suture line, in addition or instead ofextending the restraining members 118 or the strands 3013, 3015 beyondthe suture line. Finally, the suture lines may be permanently tightenedto close the atriotomy incisions, and the procedure can then becompleted according to conventional techniques.

Referring to FIG. 30 and FIG. 31, by way of non-limiting example, thetissue restraining device 100 may be implanted and the restrainingmatrix 116 may be loosely formed over the posterior leaflet 3006 of themitral valve 3005, as shown in FIG. 30. In this embodiment thetensioning strand 3013 and, if present, the fixed strand 3015 may bejoined to the middle part of the posterior portion 3004 of theannuloplasty member 3000. The strands 3013, 3015 may be left loose andlong to extend beyond the atrial incision, while the atrial incision isclosed with a running suture. The strand(s) may thus be accessed nowfrom outside the heart. The atrial suture may then be tightened over thestrands so it does not leak but not permanently tied. The heart may thenbe restarted and the patient weaned off the heart lung machine Once theheart is beating on its own, and the restraining matrix 116 may beadjusted to achieve a desired repair of the mitral valve. The positionof the restraining matrix may then be fixated, such as, for example, bytying together strands 3013, 3015 as shown in FIG. 31. Once therestraining matrix 116 is fixed, the suture line may be permanently tiedand the procedure can then be completed according to conventionaltechniques.

Referring to FIG. 16, another embodiment of a tissue restraining device1600 of the present disclosure is presented. The tissue restrainingdevice 1600, shown here in the disassembled state, may generally includea first anchor 1612, a sheath 1603, and a restraining matrix 1616 and asecond anchor 1614. In an embodiment, the restraining matrix may beformed by one or more restraining cords 1618. In an embodiment, therestraining matrix 1616 may be formed by a plurality of restraining cord1618.

Referring to FIG. 17A, the first anchor 1612 may, in an embodiment, bedesigned to attach to a common wall that separates the coronary sinusand the left atrium. To that end, in an embodiment, the first anchor maybe U-shaped or hairpin-shaped, with a first arm 1702 configured forplacement in the coronary sinus and a second arm 1704 configured forplacement in the left atrium. For clarity purposes, the first arm 1702may be referred to as the coronary sinus (CS) arm and the second arm1704 may be referred to as the left atrium (LA) arm. The arms 1702 and1704 may be biased toward one another to facilitate pinching of thecommon wall that separates the coronary sinus and the left atrium, topermit attachment of the first anchor 1612 thereto (i.e. in proximity tothe mitral valve.)

In an embodiment, the CS arm 1702 and the LA arm 1704 may have anylength, independently of one another, as long as the arms 1702, 1704, incombination, enable a secure attachment of the first anchor 1612 to thecommon wall between the coronary sinus and the left atrium. Accordingly,although the arms 1702, 1704 are illustrated as having a similar length,the arms 1702, 1704 may have different lengths. The CS arm 1702 may beconnected to the LA arm 1704 anywhere along the length of the LA arm1704, and vice versa. In an embodiment, the arms 1702, 1704 areconnected at their respective ends, as illustrated in FIG. 17A. Inanother embodiment of a first anchor 1701, the CS arm 1702 may beconnected to the LA arm 1704 away from the end of the LA arm 1704, asillustrated in FIG. 17B. In yet another embodiment, shown in FIG. 17C,the arms 1702 and 1704 are connected by a hub 1750 designed to bias thearms 1702, 1704 toward one another.

Each of the arms 1702, 1704 may, in an embodiment, include one or moreinner lumens extending through at least a portion of the arm. As will bedescribed in more details below, the inner lumens of the first arm 1702and the second arm 1704 may be sized to receive a guidewiretherethrough. As illustrated in FIG. 17A, in an embodiment, the firstarm 1702 may have a first opening 1702 a and a second opening 1702 b,and an inner lumen 1702 c, extending between and in communication withthe first opening 1702 a and the second opening 1702 b, such that aguidewire may be inserted through the inner lumen 1702. Similarly, thesecond arm 1704 may have a first opening 1704 a and a second opening1704 b, and an inner lumen 1704 c, extending between and incommunication with the first opening 1704 a and the second opening 1704b, such that a guidewire may be inserted through the inner lumen 1702 c.The one or more guidewires inserted into one or both inner lumens 1702,1704 of the first anchor 1612 may facilitate delivery of the firstanchor 1612 to a deployment site and positioning of the first anchor atthe deployment site.

The tissue restraining device 1600 may further include a sheath 1603.The sheath 1603 may be designed to be coupled to the first anchor 1612.Referring now to FIG. 18A, in an embodiment, the sheath 1603 may includean interior lumen 1800, configured to receive the LA arm 1704 of thefirst anchor 1612. In this manner, the sheath 1603 may be pulled overthe LA arm 1704 of the first anchor 1612, as shown in FIG. 19. In anembodiment, the interior lumen 1800 may be sized to receive a guidewiretherethrough. Although FIG. 19 shows the sheath 1603 having a lengthsimilar to the length of the LA arm 1704 of the first anchor 1612, thesheath 1603 may be longer or shorter than the LA arm 1704. It shouldalso be noted that the sheath 1603 may be coupled to the first anchor1612 by any other conventionally used means, such as by sutures or anadhesive.

The sheath 1603 may further include one or more contact points 1803positioned along at least a portion of the sheath 1603, as shown in FIG.18A. The contact points 1803 are the points at which the restrainingcords 1618 contact the sheath 1603. In an embodiment, the proximal endsof the restraining cords 1618 may be fixed to the sheath 1603 at theplurality of the contact points 1823, such as by adhesive, weld, orsimilar means. In an embodiment, as shown in FIG. 18B, the one or morecontact points 1803 are one or more openings 1824 positioned along atleast a portion of the sheath 1603, such that the restraining cords 1618can be inserted into the sheath 1603 or can extend out from the sheath1603. In an embodiment, the sheath 1603 includes a plurality of openings1624. The openings 1824 may be designed to be in communication with thelumen 1800. The lumen 1800, in an embodiment, may be sufficientlydesigned such that the restraining cords 1618 can be directed along thelumen 1800 and out of the lumen 1800 through the plurality of openings1824 to form the restraining matrix 1616.

Referring to FIG. 18B, in another embodiment, the sheath 1603 mayinclude multiple lumens, such as a first lumen 1801 and a second lumen1803. In the embodiment shown in FIG. 18B, the first lumen 1801 may, inan embodiment, be designed to accept a guidewire. The first lumen 1801may also be configured to receive the LA arm 1704 of the first anchor1612 therethrough, as is described above and illustrated in FIG. 19. Thesecond lumen 1803 may, in an embodiment, include a plurality of openings1824 positioned along a wall 1807 of the second lumen 1803 in spacedrelation to one another, and in communication with the second lumen1803. As is described in more detail below, the second lumen 1803 can besufficiently designed such that the restraining cords 1618 can bedirected along the second lumen 1803 and permitted to exit the secondlumen 1803 through the plurality of openings 1824 to form therestraining matrix 1616. It should be noted that although the lumens1801, 1803 are illustrated as having a similar length, the lumens 1801,1803 may be of different lengths.

The tissue restraining device 1600 may further include a second anchor1614. In an embodiment, the second anchor 1614 may be designed forplacement, for example, within the left ventricle of a heart in asubstantially opposing relation to the first anchor 1612. To this end,the second anchor 1614 provides a point to which the plurality ofrestraining cords 1618 can be attached in the left ventricle of apatient heart. A contemplated embodiment of the second anchor 1614 isshown in FIG. 6 of the instant disclosure.

The tissue restraining device 1600 may further include the restrainingmatrix 1616. Referring now to FIG. 19, when the tissue restrainingdevice 1600 is assembled, in an embodiment, the restraining matrix 1616may be formed by directing the plurality of restraining cords 1618 alonga lumen of the sheath 1603 and out through the plurality of openings1824. In an embodiment, each of the plurality of openings 1824 mayaccept a single cord 1618. Alternatively, should it be desired, each ofthe plurality of openings 1824 may accept multiple cords 1618. Each cord1618, when exiting from the sheath 1603, may be directed toward thesecond anchor 1614, individually or as a bundle. The restraining matrix1603 can have any geometric shape or pattern, depending on, for example,the shapes of the first anchor 1612 and the second anchor 1614. In anembodiment, the restraining matrix 1603 may be triangular or fan-shaped,as shown in FIG. 19.

In an embodiment, the restraining matrix 1616 can be adjustable byadjusting the restraining cords 1618 to provide a desired support to theprolapsing tissue. In an embodiment, individual cords 1618 can beadjusted independently of one another. In an embodiment, the individualcords may be adjusted either proximally of the first anchor 1612, i.e.before entering the first anchor, or distally of the second anchor 1614,i.e. after exiting the second anchor, or both. To that end, in anembodiment, a locking member may be disposed either adjacent to thefirst anchor, the second anchor, as described above, or both. To adjustthe cords in such embodiments, the locking member may be deactivated,each individual cord 1618 may be tightened or loosened as desired, and,when the desired restraining matrix support is achieved, the lockingmember may be activated to fixate the individual cords 118 in position.It will be understood that the restraining cords 1618 may be fixatedusing any other device instead of or in addition to a locking member. Inaddition, it should be mentioned that the locking member may be anylocking member known in the art.

Referring to FIG. 20, the restraining matrix 1616 may be designed suchthat a proximal section 2001 of the restraining matrix 1616 extendsalong substantially the entire length of the posterior annulus 2003 of amitral valve 2005. In another embodiment, the restraining matrix 1616may be designed such that the proximal section 2001 may substantiallydrape over P1 (anterior or medial section), P2 (middle section), and P3(posterior or lateral section) sections of the posterior leaflet 2005.In yet another embodiment, the restraining matrix may be designed suchthat the proximal section 2001 may drape over less than all threesections of the posterior leaflet 2005. To achieve that, the pluralityof openings 1824 may be disposed over a length that enables therestraining matrix 1616 to provide a desired coverage of the mitralvalve. For example, in an embodiment, the plurality of openings may bedisposed along substantially the entire length of the posterior annulus2003. In another embodiment, the plurality of openings 1824 may bedisposed along a section of the posterior annulus 2003. Accordingly, inan embodiment, the sheath 1603, or at least a lumen with the pluralityof openings in its wall, may extend along substantially the entirelength of the posterior annulus 2003. In another embodiment, the sheath1603, or at least a lumen with the plurality of openings 1824 in itswall, may extend along a section of the of the posterior annulus 2003.Alternatively or additionally, to provide the restraining matrix 1616with a desired shape, the wall 1807 of the sheath 1603 that includes theplurality of openings may be curved to approximate the shape of theposterior annulus 2003. This can be achieved by, for example, providingthe sheath 1603, the LA arm 1704 of the first anchor 1612, or both witha shape substantially similar to the shape of the posterior annulus2003.

It should be noted that the first anchor, the restraining matrix, andthe second anchor of the tissue restraining device 1600 are not limitedto embodiments shown in FIGS. 16-19, but may also include variousfeatures of the first anchor, the second anchor, and the restrainingmatrix of other embodiments of tissue restraining devices described inthe instant disclosure.

FIGS. 21A-21C illustrate an embodiment of a method for treating aprolapsed mitral valve using a tissue restraining system of the presentdisclosure. By way of a non-limiting example, a transeptal guidewire2007 may be advanced into the left ventricle of a patient heart. In anembodiment, the transeptal guidewire 2007 may be advanced along thecoronary sinus past the coronary sinus ostium, at which point thetranseptal guidewire may be directed out of the coronary sinus, into theleft atrium through the atrial septum and on to the left ventricle. Acoronary sinus guidewire 2009 may also be advanced along the coronarysinus to a point in proximity of the mitral valve.

Next, the second anchor 1614 may be advanced over the transeptalguidewire 2007 to the left ventricle of the heart of a patient. In anembodiment, the second anchor 1614 may be placed in or around the apexof the heart in the left ventricle. In addition, the sheath 1603 mayalso be delivered to a temporary position distal of the mitral valveover the transeptal guidewire 2007. That is, the transeptal guidewire2007 may be passed through a lumen in the sheath 1603 as the sheath 1603is advanced to the temporary position in the heart of the patient. In anembodiment, the sheath 1603 may be delivered to the heart with theplurality of restraining cords 1618. The cords 1618 may be coupled tothe second anchor 1614 before or after the delivery of the sheath 1603,the restraining matrix 1616, and the second anchor 1614 to the heart ofthe patient. The sheath 1603 may be stationed at the temporary positionover the transeptal guidewire 2007, until the sheath 1603 can be coupledto the first anchor 1612.

In the next step, the first anchor 1612 may be advanced over both thetranseptal guidewire 2007 and the coronary sinus guidewire 2009 to itsdeployment position in the coronary sinus and left atrium. In anembodiment, the transeptal guidewire may be passed through the LA arm1704 of the first anchor 1612 and the coronary sinus guidewire 2009 maybe passed through the CS arm 1702 of the first anchor 1612. In thismanner, the transeptal guidewire 2007 and the coronary sinus guidewire2009 assist in positioning the first anchor 1612 in a desired positionwith the CS arm 1702 in the coronary sinus and the LA arm 1704 in theleft atrium. As noted above, since the CS arm 1702 in the coronary sinusand the LA arm 1704 are biased toward one another, they are able topinch the common wall in between them thereby securely attaching thefirst anchor 1612 in proximity to the mitral valve. In an embodiment,the first anchor 1612 may be deployed in a substantially opposingrelation to the apical anchor 2005. In an embodiment, the first anchor1612 may be positioned transverse to the apical anchor 2005.

Subsequent to the deployment of the first anchor, the sheath 1603 may bepulled proximally over the transeptal guidewire to be coupled to thefirst anchor 1612. In an embodiment, the sheath 1603 may include ateether extending from the sheath 1603. By proximally pulling on theteether, the sheath 1603 may be moved proximally over the transeptalwire 2007 to be coupled with the first anchor 1612. In an embodiment,the sheath 1603 may be pulled over the LA arm 1704 of the first anchor1612. Once the sheath 1603 is coupled to the first anchor 1612, therestraining matrix 1616 may be formed between the first anchor 1612 andthe second anchor 1614. In an embodiment, the restraining matrix 1616may be fan-shaped about the mitral valve. The individual cords 1618 maythen be adjusted until all prolapsing segments of the mitral valve arecorrected. Individual cords 1618 may be tightened or loosened by pullingon individual cords. Once the individual cords 1618 have been adjusted,they can be fixated in their respective positions and trimmed to removeextra material, as desired. The restraining matrix 1616 may thus providesupport to one or more prolapsing segments of the mitral valve.

A device 2100 to provide access to a body organ, such as a heart, isshown generally in FIG. 22A. The device 2100 includes, in oneembodiment, an elongated member 2102 having a proximal section 2104, adistal section 2106, and a longitudinal axis extending the length of theelongated member 2102. Throughout this description, the term “proximal”is used to denote the side of an article that is closest to the user,and the term “distal” is used to denote the side of an article that isfurthest away from the user. The elongated member 2102 may be designedto navigate along a guide wire, a guide catheter, or both to a site ofaccess to a body organ. To that end, the member 2102 may be sufficientlyrigid axially along its length, while remaining sufficiently flexibleradially from side to side. In an embodiment, the elongated member 2102may be made from a biocompatible material, such as a biocompatibleplastic or other comparable material. The elongated member 2102 mayinclude at least one inner lumen 2110 a, 2110 b, 2112 a for passingmaterials or instrumentation therethrough.

In an embodiment, the distal end 2106 of the elongated member 2102 mayinclude a first extension member 2110 and a second extension member 2112in a substantially parallel relation to one another. In an embodiment,the first extension member 2110 and a second extension member 2112 formthe distal section 2106. In such an embodiment, the elongated member2102 may include a body 2108, with the first extension member 2110 andthe second extension member 2112 extending distally beyond the body2108. As illustrated in FIGS. 22A and 22B, the elongated member 2102 mayinclude a first inner lumen 2110 a that may extend through the elongatedmember 2102 and the first extension member 2110 to enable passing ofmaterials or instrumentation, such as, a guidewire, through theelongated member 2102 and the first extension member 2110. Moreover, theelongated member 2102 may include a second inner lumen 2112 a that mayextend through the elongated member 2102 and the second extension member2112 to enable passing of materials or instrumentation, such as, aguidewire, through the elongated member 2102 and the second extensionmember 2112.

The second extension member 2112 may, in an embodiment, be configured tobe radially deflectable relative to the elongated member 2102. In thismanner, the second extension member 2112 may be aimed at an organ towhich access is sought (“organ of interest”), such that an instrumentmay be substantially accurately directed and advanced through the secondinner lumen 2112 a to penetrate a wall of the organ of interest. Bydesign, the second extension member 2112 may be moveable from a firstaligned position, as shown in FIG. 22A, to a second deflected position,as shown in FIG. 22B. In the aligned position, the second extensionmember 2112 may be substantially aligned with the elongated member 2102,so that the elongated member 2102 may be navigated to and from a sitefor accessing the organ of interest with minimal interference from thesecond extension member 2102. In the deflected position, the secondextension member 2112 may be substantially radially deflected relativeto the elongated member 2102, so that the inner lumen 2112 a of thesecond extension member 2112 may be aligned in the direction of theorgan of interest.

The first extension member 2110, on the other hand, may be configured tobe substantially stationary. In this manner, a guidewire may be extendedthrough the elongated member 2102 and the first extension member 2110 topermit navigation of the device 2100 along the guidewire to a site foraccessing the organ of interest. In an embodiment, the first extensionmember 2110 may be configured to remain in substantial alignment withthe elongated member 2102, regardless of the position of the secondextension member 2112. In this manner, the first extension member 2110may be used as a point from which the second extension member 2112 canbe pushed into the deflected position. In an embodiment, when the secondextension member 2112 is in the aligned position, the second extensionmember 2112 and the first extension member 2110 may be positioned sideby side in a substantially parallel relationship. On the other hand,when the second extension member 2112 is in the deflected position, thesecond extension member 2112 and the first extension member 2110 may bepositioned at an angle relative to one another.

In certain embodiments, the lengths of the extension members 2110, 2112may be shorter than that of the body 2108, as illustrated in FIGS. 22Aand 22B, while in other embodiments, their lengths may be similar orlonger than the length of the body 2108. In one embodiment, the lengthof the first extension member 2110 beyond the body 2108 may be the sameas that of the second extension member 2112. In another embodiment, thelength of the first extension member 2110 beyond the body 2108 may bedifferent than that of the second extension member 2112. By providingthe extension members 2110, 2112 with different or similar lengths, theextension members 2110, 2112 may be able to accommodate the unevencurvatures or surfaces at the site for accessing the organ of interest.

In an alternative embodiment, as illustrated in FIG. 23, the firstextension member 2110 and the second extension member 2112 may have asubstantially long lengths so they can be slidably inserted into thebody 2108 to extend distally of the body 2108. In such an embodiment,the body 2108 may function essentially to maintain the first extensionmember 2110 and the second extension member 2112 in alignment with oneanother and enable the extension members 2110, 2112 to be deflectedrelative to one another. In addition, the lengths of the first extensionmember 2110 and the second extension member 2112 beyond the elongatedmember 2102 may be independently adjusted by advancing the extensionmember 2110, 2112 out of the elongated member 2102 or retracting theextension member 2110, 2112 into the elongated member 2102. To that end,the length of the first extension member 2110 beyond the elongatedmember 2102 may be adjusted to be the same as that of the secondextension member 2112, or different than that of the second extensionmember 2112. Again, by providing the extension members 2110, 2112 withdifferent or similar lengths, the extension members 2110, 2112 may beable to accommodate the uneven curvatures or surfaces at the site foraccessing the organ of interest. It will of course be understood that,although body 2108 is provided, the first extension member 2110 and thesecond extension member 2112 may be maintained in alignment with oneanother by other known techniques, for instance by the use of a singleor multiple bands wrapped about both the extension members.

The first extension member 2110 may, in an embodiment shown in FIG. 23,include at least one inner lumen 2210 for passing materials orinstrumentation therethrough. Similarly, the second extension member2112 may, in an embodiment, include at least one inner lumen 2212 forpassing materials or instrumentation therethrough. In one embodiment,the lumens 2210, 2212 of the extension members 2110, 2112 may be incommunication with one or more inner lumens 2204, 2206 of the elongatedmember. In this manner, materials or instrumentation can be passedthrough the lumens 2204, 2206 of the elongated member 2102 and into thelumens 2210, 2212 of the first and second extension members 2110, 2112,respectively, for delivery out of the extension members 2110, 2112.

To minimize or reduce friction as the elongated member 2102 travels to asite of access to the organ of interest, the outer surface of theelongated member 2102 and the extension members 2110, 2112 may be coatedwith material that reduces friction. Similarly, inner surfaces of thelumens of the elongated member 2102 and the extension members 2110, 2112may also be coated to minimize or reduce friction between the surfacesand materials or instruments being passed through the lumens of thedevice 2100. Suitable materials include, but are not limited to,polyvinylpyrrolidone, polyurethane, poly(acrylic acid), poly(methacrylicacid), poly(dimeth)acrylamide, PTFE, poly(acrylamide), polyvinybutyrol,poly(hydroxyethylmethacrylate) or combinations thereof. The outersurfaces of the elongated member 2102 and the extension members 2110,2112 may also be coated with an anti-thrombogenic coating, such asheparin (or its derivatives), urokinase, or PPack (dextrophenylalanineproline arginine chloromethylketone) to prevent thrombosis or any otheradverse reaction due to the introduction of the elongated member 2102into the body of a patient.

To deflect the second extension member 2112 relative to the elongatedmember 2102 and the first extension member 2110, the device 2100 mayfurther include a deflection mechanism 2114 disposed on the firstextension member 2110, as shown in FIGS. 22A-22B. In an embodiment, thedeflection mechanism 2114 may be activated to move the second extensionmember 2112 from the first aligned position, in which the second lumenis substantially parallel to the first extension member 2110, as shownin FIG. 22A, to the second deflected position, in which the secondextension member 2112 is substantially radially deflected from the firstextension member 2110, as shown in FIG. 22B, while the first extensionmember 2110 remains substantially aligned with body 2108. The design ofthe deflection mechanism may be selected based on the anatomy and/orapplication to ensure that the second extension member 2112, whendeflected to the second deflected position, aims at a the organ ofinterest. It will of course be understood that the deflection mechanismmay, in an embodiment, be disposed on the second extension member 2112,i.e. the extension member that is being deflected.

In one embodiment, the deflection mechanism 2114 may be an inflatabledevice 2116 of a desired shape. The inflatable device 2116 may disposedon the first extension member 2110. The inflatable device 2116 may, invarious embodiments, be round, cylindrical, conical, double-conical,tapered, oval, rectangular or may be provided with any other desiredshape. By way of a non-limiting example, FIGS. 24A-24C illustratesexemplary inflatable members 2116 of various suitable shapes. Theinflatable device 2116 may be formed of a pliable, resilient,conformable, and strong material, including but not limited to urethane,polyethylene terephthalate (PET), nylon elastomer and other similarpolymers. In an embodiment, the size and shape of the inflatable device2116 may depend on, for example, the anatomy of the organ of interest,as is describe below, and can be determined from medical literature,patient observation, or both. Depending on the anatomy and location ofthe organ of interest, the second extension member 2112 may have alength similar or different than that of the first extension member 2110so as the second extension member 2112 is provided with sufficientlength to be placed in proximity of a body organ of interest.

To actuate the inflatable device 2116, a third lumen 2110 b may beprovided so as to extend through the elongated member 2102 and the firstextension member 2110 (referred herein to as an inflation lumen 2110 b).The inflatable device 2116, in one embodiment, may be inflated with afluid, such as for example, saline. In some embodiment, the inflatabledevice 2116 may be inflated with a contrast solution, such that theinflatable device 2116 may be easily observed during the procedure withknown imaging techniques. Of course, a gas can also be used to inflatethe inflatable member 2116. The inflatable device 2116 on the firstextension member 2110 may be configured to move the second extensionmember 2112 from the first aligned position, when the inflatable device2116 is inflated, to the second deflated position to place the secondextension member 2112 in a desired position. On the other hand, theinflatable device 2116 on the first extension member 2110 may beconfigured to allow the second extension member 2112 to return to thefirst aligned position along the first extension lumen 2110, when theinflatable device 2116 is deflated, to facilitate removal of the device2100 from the patient.

In another embodiment, the deflection mechanism 2110 may be aself-expanding device 2400 of a desired shape, as shown in FIGS.25A-25B. Such self-expanding device 2400 may be, in various embodiments,round, cylindrical, conical, double-conical, tapered, oval, rectangularor may be provided with any other desired shape. The self-expandingdevice 2400 may, in an embodiment, be formed of a shape memorymaterials, including, but not limited to, nickel-titanium based alloys,indium-titanium based alloys, nickel-aluminum based alloys,nickel-gallium based alloys, copper based alloys, gold-cadmium basedalloys, silver-cadmium based alloys, indium-cadmium based alloys,manganese-copper based alloys, iron-platinum based alloys, andiron-palladium based alloys. In an embodiment, the self-expanding device2400 may be restricted to a substantially small diameter by using asheath 2402 during the delivery of the self-expanding device 2400 to asite of access to the organ of interest. In such an embodiment, thedevice 2100 may include an actuating wire 2404 extending through theelongated member 2102, first extension member 2110, or both andconnected to the sheath 2402 for actuating the sheath. To activate theself-expanding device 2400 may be activated, i.e. allow theself-expanding device 2400 to expand, the sheath 2402 may be pulledproximally by the actuating wire 2404 to uncover the self-expandingdevice 2400 To collapse the self-expanding device 2400, the sheath 2402may be advanced by the actuating wire 2404 distally to cover theself-expanding device 2400. The self-expanding member 2400 may beconfigured to move the second extension member 2112 from the firstaligned position to the second deflated position when the self-expandingdevice 2400 is expanded, to place the second extension member 2112 at adesired position. On the other hand, the self-expanding member 2400 maybe configured to allow the second extension member 2112 to return to thefirst aligned position, along the first extension member 2110, when theself-expanding member 2400 is collapsed, so that the device 2100 may bewithdrawn from the patient.

In yet another embodiment, the deflection mechanism 2114 may be amechanically-expandable device 2500 of a desired shape, as shown inFIGS. 26A-26B. Such mechanically-expandable device may, in variousembodiments, be round, cylindrical, conical, double-conical, tapered,oval, rectangular or may be provided with any other desired shape. Themechanically-expandable device 2500 may be formed from a flexible andresilient material, such as plastics or other comparable materials. Themechanically-expandable device 2500 may include a proximal end 2502 anddistal end 2504 and a collapsible body 2506 between the proximal end2502 and the distal end 2504. The mechanically expanding device 2500may, in an embodiment, be slidably disposed over the first extensionmember 2110. The mechanically-expandable device 2500 may be moved from acollapsed configuration to an expanded configuration by decreasing thedistance between its proximal end 2502 and the distal end 2504, as shownin FIG. 26B. On the other hand, the mechanically-expandable device 2500may be returned to the collapsed configuration by increasing thedistance between its proximal end 2502 and the distal end 2504, as shownin FIG. 26A. In an embodiment, the device 2100 may include an actuatingwire 2508 configured to increase or decrease the distance between theproximal end 2502 and the distal end 2504 of the mechanically-expandabledevice 2500. The mechanically-expandable device 2500 may be configuredto move the second extension member 2110 from the first aligned positionto the second deflated position, when the mechanically-expandable device2500 is moved from the collapsed configuration to the expandedconfiguration, to place the second extension member 2112 into a desiredposition. On the other hand, the mechanically-expandable device 2500 maybe configured allow the second extension member 2112 to return to thefirst aligned position along the first extension member 2110, whenmechanically-expandable device 2500 is collapsed, for example, to allowthe device 2100 to be withdrawn from the patient. Themechanically-expandable device 2500 may be connected to the firstextension member by any technique that may allow themechanically-expandable member to be moved from the collapsedconfiguration to the expanded configuration and back. in an embodiment,the proximal end 2502 of the mechanically-expandable device 2500 may beconnected to the elongated member 2102, while the distal end 2504 of themechanically-expandable device 2500 may be connected to the firstextension member.

Referring back to FIGS. 22A and 22B, the device 2100 may, in anembodiment, further include a stopper 2118 disposed on the firstextension member. The stopper 2118 may be disposed at or near the distalend of the first extension member 2110 in order to anchor the device2100 in place during the procedure. In an embodiment, the stopper 2118may be designed to control the depth of advancement of the device 2100past the site for access the organ of interest. The stopper 2118 may beprovided with size sufficient to prevent the device 2100 from advancingbeyond a desired distance into a designated cavity. In other words, thestopper 2118 may be provided with a size sufficiently large to minimizeits entrance from a cavity into another cavity with a relatively smallerdiameter. The stopper 2118 may be inflatable, self-expanding, ormechanically-expanded, such as described above in regard to thedeflection mechanism 2114.

In an embodiment, the deflection mechanism 2114 and the stopper 2118 maybe integrated. For example, as illustrated in FIG. 27A, the mechanism2600 may be configured to deflect the second extension member 2112radially away from the first extension member 2110, and thus serve asthe deflection mechanism 2114. Moreover, the mechanism 2600 may alsoconfigured to limit the depth of advancement of the device 2100 from abody cavity 2602 having one diameter into a body cavity 2604 having asmaller diameter, and thus serves as the stopper 2118. In anotherembodiment, as illustrated in FIG. 27B, the deflection mechanism 2114and the stopper 2118 may be two distinct mechanisms. In such anembodiment, the deflection mechanism 2114 may be responsible fordeflecting the second extension member 2112 radially away from the firstextension member 2110, while the stopper 2118 may be responsible forlimiting the depth of advancement of the device 2100 into the bodycavity 2604. Although the device 2100 is illustrated with the deflectionmechanism 2114 and the stopper 2118 disposed on the same extensionmember, the deflection mechanism 2114 and the stopper 2118 may belocated on different extension members.

As shown in FIG. 22A, the device 2100 may further include an orientationmechanism 2120. During the procedure, the device 2100 may need to berotated by the user to place the device 2100 into a desired orientation.The orientation mechanism 2120 may provide the user with the ability tomonitor and/or confirm the location and orientation of the device 2100at any given time during the procedure.

In an embodiment, the orientation mechanism 2120 may include one or moreradiopaque (“RO”) markers or bands. Such RO markers or bands may beformed from radiopaque materials such as barium sulfate, tantalum, orother materials known to increase radiopacity. The RO markers or bandsmay be placed at various locations along the elongated member 2102. Inan embodiment, the RO markers or bands may be placed at variouslocations along a length of the first extension member 2110 and thesecond extension member 2112. The RO markers or bands may allow the userto monitor the location and orientation of the device 2100 during theprocedure by, for example, fluoroscopy.

In another embodiment, instead of RO markers or bands, the echogenic ormagnetically responsive markers, or both may be employed as theorientation mechanism 2120. The echogenic or magnetically responsivemarkers may allow the user to monitor the location and orientation ofthe device 2100 using ultrasound or Mill techniques, respectively.

In yet another embodiment, the orientation mechanism 2120 may includeone or more electrical leads. In an embodiment, one or more electricalleads may be positioned at or near the distal end of the elongatedmember 2102 in a desired pattern. The one or more electrical leads maybe configured to detect a unique electrographic pattern when theelongated member is in a desired position and orientation.

In operation, the device 2100 may be used to gain access to a variety ofbody organs. By way of a non-limiting example the device 2100 may beemployed to gain access to the left atrium of a heart via a transeptalapproach, as illustrated in FIGS. 28A-28D.

First, a peripheral venous access may be obtained via, for example,internal jugular, subclavian, or femoral veins. A guidewire 2700 ofappropriate stiffness may then be introduced into peripheral venoussystem (not shown) and advanced through the right atrium 2702 intocoronary sinus (CS) 2704, as shown in FIG. 28A. The advancement of aguidewire into coronary sinus may be performed under fluoroscopicguidance, echocardiographic guidance or both using a variety of imagingtechniques. In an embodiment, a guidewire may be introduced into CSusing a CS guide catheter. For the purpose of clarity, the guidewireintroduced into CS may be referred herein to as the CS guidewire.

Once the CS guidewire 2700 is in place in CS 2704, the device 2100 maybe advanced over the CS guidewire 2700 into the right atrium 2702, asshown in FIG. 28B The CS guidewire 2700, in an embodiment, may be passedthrough an inner lumen of the body 2108 of the elongated member 2102 andan inner lumen of the first extension member 2110. When the device 2100is inside the right atrium 2702, the stopper 2118, which in FIGS.28A-28D is illustrated as integral with the deflation mechanism 2114, onthe first extension member 2110 may be activated, as shown in FIG. 28C.The device 2100 may then be advanced further along the CS guidewire 2700until the stopper 2118 engages the CS ostium 2708. At this point, thedevice 2100 is at the site of access into the left atrium 2706.

Next, the deflection mechanism 2114 on the first extension member 2110may be activated to radially deflect the second extension member 2112 toa desired position. In one embodiment, the desired position of thesecond extension member 2112 may be such that the distance between thedistal tip of the first extension member 2110 and the distal tip of thesecond extension member 2112 is greater that the radius of CS ostium2708. In other words, the desired position of the second extensionmember 2112 may be, in an embodiment, such that when the secondextension member 2112 is deflected, the distal tip of the secondextension member 2110 is outside the CS ostium 2708. It should of coursebe understood that in the embodiments where the deflection mechanismalso serves as a stopper, the deflection mechanism may be activatedbefore the device 2100 is at the site of access to the left atrium. Inthis manner, the device 2100 may be prevented from being advanced pastthe site of access to the left atrium.

Once the second extension member 2112 is deflected, the device 2100 maybe oriented, with the aid of the orientation mechanism 2120, such thatthe distal end of the second extension member 2112 is aimed at theatrial septum. Another guidewire 2710, referred herein to as the leftatrium (LA) guidewire or transeptal guidewire, may then be advancedthrough an inner lumen of the body 2108 of the elongated member 2102 andan inner lumen of the second extension member 2112 to penetrate atissue, i.e. the atrial septum, to enter the left atrium 2706, as shownin FIG. 28E. At this point, the device 2100 may be removed from thepatient, and the LA guidewire 2710 may be used for the advancement ofcatheters or other devices into the left atrium 2706. For example, theleft atrium guidewire 2710 may be utilized to advance catheters or otherdevices into the left atrium 2706 for such procedures as mitral valveintervention, ablation, left atrium appendage intervention among others.In an embodiment, the left atrium guidewire 2710 may be further advancesinto the left ventricle

By way of non-limiting example, when the device 2100 may be withdrawn,the CS guidewire 2700 may be left in place. In such an embodiment, theCS guidewire 2700 and the LA or transeptal guidewire 2710 may be used asdescribed above to deploy a tissue restraining device of the presentdisclosure to repair a prolapsing mitral valve.

The devices, systems and methods of the present disclosure are describedin the following Examples, which are set forth to aid in theunderstanding of the disclosure, and should not be construed to limit inany way the scope of the disclosure as defined in the claims whichfollow thereafter. The following examples are put forth so as to providethose of ordinary skill in the art with a complete disclosure anddescription of how to make and use the devices and methods of thepresent disclosure, and are not intended to limit the scope of what theinventors regard as their invention nor are they intended to representthat the experiments below are all or the only experiments performed.Efforts have been made to ensure accuracy with respect to numbers used(e.g. amounts, temperature, etc.) but some experimental errors anddeviations should be accounted for.

EXAMPLE 1 Restraining a Native Mitral Valve In Vivo

The goal of the study was to assess whether a set of cords emanatingfrom the coronary sinus (CS), entering the left atrium (LA) just abovethe posterior mitral annulus, traversing the orifice of the mitral valveand anchored to the left ventricle (LV) apex can restrain a prolapsingP2 segment and eliminate mitral regurgitation (MR).

The steps of this procedure are presented in FIGS. 29A-29N. An isolatedcalf heart was utilized. Atria was excised, coronaries were ligated,aortic valve was excised, ascending aorta was oversewn and CS wasunroofed. Saline was infused into a ascending aorta through a 16 gaugeneedle to pressurize the left ventricle, as shown in FIGS. 29A-29B.

P2 segment was marked as shown in FIGS. 29C and 29D. Multiple cordaetendinae to P2 segment of the valve were cut to create a prolapse andMR, as shown in FIGS. 29E and 29F.

To fix the prolapse, five individual CV-5 Gortex sutures were passedfrom CS into LA just above the annulus of the mitral valve just above P2segment, as shown in FIGS. 29G and 29H.

The sutures were spaced about 2 mm apart and spanned the prolapsing P2segment. The distal ends of sutures were tied together, passed throughthe mitral valve and LV apex, and anchored to LV apex with anothersuture, as shown in FIGS. 29I and 29J.

The sutures, which are shown as loose in FIGS. 29K and 29L, weretightened to restrain the prolapsing segment P2 and eliminate MR, asshown in FIGS. 29M and 29L.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety.

While the invention has been described in connection with the specificembodiments thereof, it will be understood that it is capable of furthermodification. Furthermore, this application is intended to cover anyvariations, uses, or adaptations of the invention, including suchdepartures from the present disclosure as come within known or customarypractice in the art to which the invention pertains, and as fall withinthe scope of the appended claims.

What is claimed is:
 1. A tissue restraining device comprising: anannuloplasty member for attachment to a valve annulus of a cardiacvalve, the annuloplasty member defining an opening; an anchor situatedin a spaced relation to the annuloplasty member on an opposite side ofthe cardiac valve; a plurality of restraining cords forming arestraining matrix extending from the annuloplasty member into theopening and toward the anchor; and a tensioning strand extendingdistally from the restraining matrix, passing through the anchor, andextending proximally past the anchor so the restraining matrix isadjustable as a single unit to change a tension in the restrainingmatrix.
 2. The device of claim 1, wherein the restraining cords convergeat their distal ends to form an apex between the annuloplasty member andthe anchor, and the tensioning strand extends from the apex.
 3. Thedevice of claim 1, wherein the tensioning strand extends through theannuloplasty member.
 4. The device of claim 1, wherein the restrainingcords are individually adjustable to change a tension in the restrainingmatrix.
 5. The device of claim 4, wherein the annuloplasty memberincludes a second strand to provide a tying point for the tensioningstrand.
 6. The device of claim 1, wherein the anchor includes a loop forpassing the tensioning strand therethrough.
 7. The device of claim 1,wherein the annuloplasty member is configured to be implantedsubstantially along an annulus of a mitral valve, the anchor isconfigured to be implanted in a left ventricle, and, when therestraining device is implanted into the mitral valve, the restrainingmatrix is extended between the annuloplasty member and the anchor todrape over the leaflet.
 8. The device of claim 1, wherein theannuloplasty member includes one or more inner lumens and one or moreopenings in communication with the inner lumens to allow a pluralityrestraining cords to be passed through the inner lumens of the ring andout of the plurality of openings to form the restraining matrix.
 9. Thedevice of claim 1, wherein the restraining matrix further comprisescross-restraint members extending between the plurality of therestraining cords.
 10. A method of treatment of a mitral valvecomprising: attaching an annuloplasty member substantially along thevalve annulus; embedding an anchor into a tissue in a left ventricle;extending a restraining matrix from the annuloplasty member over aleaflet of the mitral valve, wherein a tensioning strand extendsdistally from the restraining matrix, through the anchor, and proximallypast the anchor; and adjusting the restraining matrix to correct one ormore prolapsing segments of the leaflet by changing a tension in thetensioning strand.
 11. The method of claim 10, wherein in the step ofadjusting, the restraining matrix is formed by one or more restrainingcords.
 12. The method of claim 11, wherein in the step of adjusting, therestraining matrix is adjusted by individually adjusting the restrainingcords.
 13. The method of claim 10, wherein in the step of adjusting, therestraining matrix is adjusted by passing the tensioning strand througha loop of the anchor and pulling the tensioning strand away from theanchor.
 14. The method of claim 13, wherein in the step of adjusting,the annuloplasty member includes a second strand to provide a tyingpoint for the first strand to fix the restraining matrix in a desiredtension.
 15. The method of claim 11, wherein the restraining cordsconverge at their distal ends to form an apex between the annuloplastymember and the anchor, and the tensioning strand extends from the apex.